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CDE Detailed Report
This report contains detailed information about the selected CDEs.
Note: If at least one CDE was selected from a copyright- or trademark-protected instrument/scale then all of the CDEs from that instrument/scale are included in this report.
Disease: General (For all diseases)
Sub-Domain: Protocol Deviations
CRF: Protocol Deviations
Item count: 3 (3 distinct CDEs)
CDE ID
CDE Name
Variable Name
Definition / Description
Question Text
Permissible Value
Description
Data Type
Instructions
References
Population
Classification (e.g., Core)
Version #
Version Date
Aliases for Variable Name
CRF Module / Guideline
© or TM
Sub-Domain
Domain
Previous Title
Size
Input Restrictions
Min Value
Max Value
Measurement Type
LOINC ID
SNOMED
caDSR ID
CDISC ID
C02206
Protocol deviation occurrence indicator
ProtocolDeviatnOccurInd
Indicator of whether any protocol deviations took place during the participant's/subject's involvement in the study.
Were there any deviations from the protocol that occurred during the care of this participant/subject, after enrollment and before participant/subject exited the study?
Yes;No;Unknown;
Yes;No;Unknown;
Alphanumeric
Choose one. If this question is answered YES then at least one protocol deviation should be recorded.
No references available
Adult;Pediatric
Supplemental
3.0
7/18/2013
PRTCL_DV_YN
Protocol Deviations
Protocol Deviations
Protocol Experience
Protocol deviation occurrence indicator
 
Single Pre-Defined Value Selected
     
3181141
 
C02205
Protocol deviation description text
ProtocolDeviatnDescripTxt
Description of the protocol deviation which includes reasons and contributing factors.
Description of Protocol Deviation
  
Alphanumeric
Record what occurred and why. For example, an expired drug was used by a new coordinator who did not check the expiration date because of incomplete training on the protocol. The description should also include remedies taken. In this case, the participant/subject was called to return the drug and was issued unexpired medication. Further, the coordinator received complete training and was certified on the protocol.
No references available
Adult;Pediatric
Supplemental
3.0
7/18/2013
PROT_DEV_DESC_TXT
Protocol Deviations
Protocol Deviations
Protocol Experience
Protocol deviation description text
4000
Free-Form Entry
     
2435038
 
C02204
Protocol deviation occurrence date and time
ProtocolDeviatnOccurDateTime
Date (and time, if applicable and known) on which the protocol deviation occurred
Date Deviation Occurred
  
Date or Date & Time
Record the date the protocol deviation occurred. The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.) and in the format acceptable to the study database.
No references available
Adult;Pediatric
Supplemental
3.0
7/18/2013
PROT_DEV_OCUR_DT
Protocol Deviations
Protocol Deviations
Protocol Experience
Protocol deviation occurrence date and time
 
Free-Form Entry
     
2434998
 
12-17-2018
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